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Point-of-Care Influenza and Strep A Assays Approved by the FDA

On the heels of the newly approved baloxavir marboxil for the treatment of acute uncomplicated flu (flu) in patients 12…

On the heels of the newly approved baloxavir marboxil for the treatment of acute uncomplicated flu (flu) in patients 12 years of age and older who have been symptomatic for a maximum of 48 hours, the American Food and Drug Administration (FDA) has cleared Next Generation AB 2 and Strep A 2 Molecular Assays from Abbott, which have been shown to improve in the fastest possible time to results among marketed analyzes. Both tests were also granted a CLIA certificate for cancellation.

The Influence Analysis provides a molecular detection coefficient and influenza A and B differentiation results of 13 minutes or less with a compact storage system that enables streamlined tests. The test also enables room temperature storage for all test components, according to a statement by Abbott, simplifying and streamlining sample ordering and storage.

The Strep A 2 assay, which provides a molecular detection of group A Streptococcus bacterial nucleic acid, can yield results for 6 minutes or less. Positive results can be called as early as 2 minutes, without any cultural confirmation required.

The analyzes are supported by the ID NOW platform, the first CLIA-terminated molecular platform with an instrument-based isothermal system for qualitative detection of infectious diseases. The initial influenza A & B and Strep A platform analysis was approved for marketed use in 201

4 and 2015, with a third analysis for respiratory syncytial virus purified in 2016.

With FDA approval, Abbot now expects to Provide new analyzes for use this fall.

It has been a particularly busy week for marketed influenza preparations with the baloxavir marboxil approval and updated indication for the quadrival influenza vaccine to include childcare patients.

The ability to get early excuses for positive molecular test results in a short period of time is a “game change” for treatment purposes, according to Gregory J. Berry, PhD, Director of Molecular Diagnostics, Northwell Health Laboratories in Lake Success, New York.

“Rapid testing can also help reduce the incorrect use of antibiotics, which may occur when treatment is solely based on patient symptoms and contributes to antibiotic responses instead,” Berry said in a statement.

This article originally appeared as “FDA approves Rapid Flu & Strep Assays” on MD

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